Knobbe Martens Achieves Standout Ranking at 2024 Financial Times Innovative Lawyers North America Awards
IRVINE, Calif., December 11, 2024 – Knobbe Martens is honored to announce that the firm received a “Standout” recognition, the highest possible tier, in the Healthcare & Life Sciences category...
Maria Anderson Named to USPTO Patent Public Advisory Committee
SEATTLE, December 10, 2024 – Knobbe Martens is pleased to announce that partner Maria Anderson has been named to the United States Patent and Trademark Office (USPTO) Patent Public Advisory...
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines "genetic modification" as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.
